FrailtyNCT04835090
Comparison of Three Frailty Screening Tools
An observational study of Frailty, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The financial health care and social impact of the frailty of the elderly is an important issue for preventive health care in various countries around the world. The Taiwan government launched the long-term care 10-year plan version 2.0 in 2017 and expanded service target with older people with frailty as a service… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- screening test
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2021to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling elderly aged 65 or older referral by the personnel in outpatient department in a hospital, community care centers, activity centers, health centers, C tiers of community care service system, health stations, love angel stations, long-term care centers, and community development associations.
Who may be able to join
- Age of 65 years and older with community-dwelling in Taoyuan and Hsinchu city, Miaoli county
- Communicate with Mandarin, Taiwanese, or Hakka
- Agreement to participant the frailty screening three times within half a year after explanation, and have signed an informed consent.
Who cannot join
- Living in a hospital or nursing home.
- Dementia.
- Bedridden or terminal illness.
- Taking drugs for Alzheimer's disease or antidepressant drugs.
- Stroke or upper or lower limb surgery in the past three months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wei Gong Memorial Hospital
Toufen Township, 35159
Meei-Horng Yang, MSN, 886-37-676811 ext. 88969, celinayang2014@gmail.com
Meei-Horng Yang, MSN
About this study
Official title: Comparison of the State Transition, Psychometric Attributes and Feasibility of Three Frailty Screening Tools in Community-dwelling Elderly
The financial health care and social impact of the frailty of the elderly is an important issue for preventive health care in various countries around the world. The Taiwan government launched the long-term care 10-year plan version 2.0 in 2017 and expanded service target with older people with frailty as a service need. There is no consensus on the definition of frailty. However, there are many existing frailty screening instruments. It is very important to choose accurate and simple and rapid tools for screening to reduce the extra medical costs caused by negative outcomes of frailty. The primary purpose of this study is to understand the transition changes of the elderly in the community during the six months of frail state (robust, pre-frail, frail), and examine the validity of the frailty, physical function (handgrip strength, walking speed) to predict negative outcomes (falls, institutionalization/hospitalization), and will be compared with the results of three frailty screening tools. The secondary purpose is to compare the feasibility (screening time, screening completion rate, equipment and space) of the three tools for the frailty screening of the elderly in the community.
Read the detailed description
This is a prospective study with six month follow-up among community-dwelling elderly aged 65 or older. Agreement between instruments, Frail state transition changes, feasibility, internal consistency, concurrent and predictive validity, convergent validity of instruments will be evaluated and compared. The participants' recruitment strategies will be through referrals by the personnel in outpatient department in a hospital, community care centers, health centers, C tiers of community care service system, love angel stations etc. We focused on three available instruments based on literature review and expert opinions for community-dwelling elderly care: Kihon Checklist (KCL), Study of Osteoporotic Fractures (SOF), and frailty phenotype (FP) screening tools. Using G-power3.1 for sample size estimation, 80 subjects will be needed. Based on the estimated loss rate is 30%, so 110 participants need to be recruited.
The screening sequence of this research will carry out with the Randomization block. There are six sequence combinations with three frailty screening tools. The researcher read the questionnaire one by one item, and then will fill the participants' answers into the data collection sheets. The physical function test is performed by the researcher.
This study was approved by the institutional Review Board. All participants will be asked to complete written informed consent. The statistical method adopts multivariate repeated measure analysis to detect the transition of frailty state. The area under the curve (AUC) will be used to examine the predictive ability on body function (grip strength, walking speed) and negative outcomes (falls, hospitalization) of the three frailty screening tools.
The anticipated benefits of this study will include (1) clinical practice: provide the screening time, completion rate, reliability and validity of the frailty screening tools to clinical health care professionals with reference to the selection of frailty screening tools for the community-dwelling elderly. Predicting the cut-off point of screening for falls or institutionalization/hospitalization of elderly people in the community can be used in nursing clinical practice to explain the screening results and risk assessment of falls and hospitalization to patients to prevent or delay the frailty progress. (2) academic research: provide a six-month observation of the changes in the frailty status of the elderly in the community in Taiwan, increase the understanding of the frailty transition of the elderly in the community, and identify frailty screening tools that have better prediction of physical functions and negative results. (3) National development: The results of this study are provided to the government as a reference for optimizing Taiwan's long-term care 2.0 policy formulation.
- Conditions
- Frailty
- Being tested
- screening test
- Keywords
- frailty, transition, psychometric attributes, feasibility, screening, community-dwelling, elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening testOther
using three screening tools
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frailty Phenotype (FP)
The FP measurement tool consists five items (yes/no) which includes handgrip strength measured via a dynamometer (in kilograms), self-reported weight loss, self-reported exhaustion, 5 meter usual gait speed (in seconds), and physical activity level measured by the Taiwan International Physical Activity Questionnaire Short Form (Taiwanese version of the IPAQ), which was used to calculate calorie consumption. The number of criteria (a 6-level ordinal variable ranging from 0 to 5) is categorized into a 3-level variable depicting robust (none of the criteria), pre-frail (one or two criteria) and frail (three or more criteria).
Measured: This will be measured at baseline, three months and six months.
Change in Study of Osteoporotic Fractures (SOF)
The SOF consists three items (yes/no) which includes weight loss (unintentional); inability to rise from a chair 5 times without the use of arms; and reduced energy level. Frail status was defined as robust (none of components), prefrail (one component), and frail (two or more components).
Measured: This will be measured at baseline, three months and six months.
Change in Kihon Checklist (KCL)
The KCL consists of 25 items (yes/no) divided into seven domains: physical strength, nutrition, eating, socialization, memory, mood; each domain is rated on a pass (0)/fail (1) basis, and the sum of all indices ranges from 0 (no frailty) to 25 (severe frailty); a higher score indicates worse functioning. Frailty status was defined as robust (0-3 scores), prefrail (4-7 scores), and frail (8 scores or more ).
Measured: This will be measured at baseline, three months and six months.
Change in Handgrip Strength
handgrip strength measured via a dynamometer (in kilograms)
Measured: This will be measured at baseline, three months and six months.
Change in Gait Speed
5 meter usual gait speed (in seconds)
Measured: This will be measured at baseline, three months and six months.
Secondary outcomes (4)
Screening Time
Use a stopwatch to record the time from the beginning to the end of each measurement tool at baseline . Units of measurement is minutes and seconds
Measured: This will be measured at baseline.
Screening Completion
The screening completion rate is defined as completing the each tool for the frailty screening of the elderly in the community at baseline.
Measured: This will be measured at baseline.
Change in Number of Hospitalization
occurence of hospitalization
Measured: This will be measured at three months and six months.
Change in Number of Falls
occurence of falls
Measured: This will be measured at three months and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Mar 2021
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wei Gong Memorial Hospital
- Responsible party
- Principal investigator, Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences
- Investigators
- Hung-Ru Lin, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835090
- Sponsor's protocol ID
- 200836
- Status last verified
- Apr 2021
- First submitted
- 22 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbasi M, Khera S, Dabravolskaj J, Garrison M, King S. Identification of Frailty in Primary Care: Feasibility and Acceptability of Recommended Case Finding Tools Within a Primary Care Integrated Seniors' Program. Gerontol Geriatr Med. 2019 May 15;5:2333721419848153. doi: 10.1177/2333721419848153. eCollection 2019 Jan-Dec.
PubMed 31192278Ambagtsheer RC, Thompson MQ, Archibald MM, Casey MG, Schultz TJ. Diagnostic test accuracy of self-reported screening instruments in identifying frailty in community-dwelling older people: A systematic review. Geriatr Gerontol Int. 2020 Jan;20(1):14-24. doi: 10.1111/ggi.13810. Epub 2019 Nov 14.
PubMed 31729157Fukutomi E, Okumiya K, Wada T, Sakamoto R, Ishimoto Y, Kimura Y, Kasahara Y, Chen WL, Imai H, Fujisawa M, Otuka K, Matsubayashi K. Importance of cognitive assessment as part of the "Kihon Checklist" developed by the Japanese Ministry of Health, Labor and Welfare for prediction of frailty at a 2-year follow up. Geriatr Gerontol Int. 2013 Jul;13(3):654-62. doi: 10.1111/j.1447-0594.2012.00959.x. Epub 2012 Nov 22.
PubMed 23170783Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Kiely DK, Cupples LA, Lipsitz LA. Validation and comparison of two frailty indexes: The MOBILIZE Boston Study. J Am Geriatr Soc. 2009 Sep;57(9):1532-9. doi: 10.1111/j.1532-5415.2009.02394.x. Epub 2009 Jul 21.
PubMed 19682112Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.
PubMed 26927924
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the State Transition, Psychometric Attributes and Feasibility of Three Frailty Screening Tools in Community-dwelling Elderly
- ClinicalTrials.gov ID
- NCT04835090
- Acronym / sponsor ID
- 200836
- Conditions
- Frailty
- Keywords
- frailty, transition, psychometric attributes, feasibility, screening, community-dwelling, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Wei Gong Memorial Hospital
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The financial health care and social impact of the frailty of the elderly is an important issue for preventive health care in various countries around the world. The Taiwan government launched the long-term care 10-year plan version 2.0 in 2017 and expanded service target with older people with frailty as a service need. There is no consensus on the definition of frailty. However, there are many existing frailty screening instruments. It is very important to choose accurate and simple and rapid tools for screening to reduce the extra medical costs caused by negative outcomes of frailty. The primary purpose of this study is to understand the transition changes of the elderly in the community during the six months of frail state (robust, pre-frail, frail), and examine the validity of the frailty, physical function (handgrip strength, walking speed) to predict negative outcomes (falls, institutionalization/hospitalization), and will be compared with the results of three frailty screening tools. The secondary purpose is to compare the feasibility (screening time, screening completion rate, equipment and space) of the three tools for the frailty screening of the elderly in the community.
Detailed description
This is a prospective study with six month follow-up among community-dwelling elderly aged 65 or older. Agreement between instruments, Frail state transition changes, feasibility, internal consistency, concurrent and predictive validity, convergent validity of instruments will be evaluated and compared. The participants' recruitment strategies will be through referrals by the personnel in outpatient department in a hospital, community care centers, health centers, C tiers of community care service system, love angel stations etc. We focused on three available instruments based on literature review and expert opinions for community-dwelling elderly care: Kihon Checklist (KCL), Study of Osteoporotic Fractures (SOF), and frailty phenotype (FP) screening tools. Using G-power3.1 for sample size estimation, 80 subjects will be needed. Based on the estimated loss rate is 30%, so 110 participants need to be recruited.
The screening sequence of this research will carry out with the Randomization block. There are six sequence combinations with three frailty screening tools. The researcher read the questionnaire one by one item, and then will fill the participants' answers into the data collection sheets. The physical function test is performed by the researcher.
This study was approved by the institutional Review Board. All participants will be asked to complete written informed consent. The statistical method adopts multivariate repeated measure analysis to detect the transition of frailty state. The area under the curve (AUC) will be used to examine the predictive ability on body function (grip strength, walking speed) and negative outcomes (falls, hospitalization) of the three frailty screening tools.
The anticipated benefits of this study will include (1) clinical practice: provide the screening time, completion rate, reliability and validity of the frailty screening tools to clinical health care professionals with reference to the selection of frailty screening tools for the community-dwelling elderly. Predicting the cut-off point of screening for falls or institutionalization/hospitalization of elderly people in the community can be used in nursing clinical practice to explain the screening results and risk assessment of falls and hospitalization to patients to prevent or delay the frailty progress. (2) academic research: provide a six-month observation of the changes in the frailty status of the elderly in the community in Taiwan, increase the understanding of the frailty transition of the elderly in the community, and identify frailty screening tools that have better prediction of physical functions and negative results. (3) National development: The results of this study are provided to the government as a reference for optimizing Taiwan's long-term care 2.0 policy formulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling elderly aged 65 or older referral by the personnel in outpatient department in a hospital, community care centers, activity centers, health centers, C tiers of community care service system, health stations, love angel stations, long-term care centers, and community development associations.
Key inclusion criteria (3 listed)
- Age of 65 years and older with community-dwelling in Taoyuan and Hsinchu city, Miaoli county
- Communicate with Mandarin, Taiwanese, or Hakka
- Agreement to participant the frailty screening three times within half a year after explanation, and have signed an informed consent.
Key exclusion criteria (5 listed)
- Living in a hospital or nursing home.
- Dementia.
- Bedridden or terminal illness.
- Taking drugs for Alzheimer's disease or antidepressant drugs.
- Stroke or upper or lower limb surgery in the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening testusing three screening tools | Other | – |
Primary outcome
Change in Frailty Phenotype (FP)
Time frame: This will be measured at baseline, three months and six months.
The FP measurement tool consists five items (yes/no) which includes handgrip strength measured via a dynamometer (in kilograms), self-reported weight loss, self-reported exhaustion, 5 meter usual gait speed (in seconds), and physical activity level measured by the Taiwan International Physical Activity Questionnaire Short Form (Taiwanese version of the IPAQ), which was used to calculate calorie consumption. The number of criteria (a 6-level ordinal variable ranging from 0 to 5) is categorized into a 3-level variable depicting robust (none of the criteria), pre-frail (one or two criteria) and frail (three or more criteria).
Change in Study of Osteoporotic Fractures (SOF)
Time frame: This will be measured at baseline, three months and six months.
The SOF consists three items (yes/no) which includes weight loss (unintentional); inability to rise from a chair 5 times without the use of arms; and reduced energy level. Frail status was defined as robust (none of components), prefrail (one component), and frail (two or more components).
Change in Kihon Checklist (KCL)
Time frame: This will be measured at baseline, three months and six months.
The KCL consists of 25 items (yes/no) divided into seven domains: physical strength, nutrition, eating, socialization, memory, mood; each domain is rated on a pass (0)/fail (1) basis, and the sum of all indices ranges from 0 (no frailty) to 25 (severe frailty); a higher score indicates worse functioning. Frailty status was defined as robust (0-3 scores), prefrail (4-7 scores), and frail (8 scores or more ).
Change in Handgrip Strength
Time frame: This will be measured at baseline, three months and six months.
handgrip strength measured via a dynamometer (in kilograms)
Change in Gait Speed
Time frame: This will be measured at baseline, three months and six months.
5 meter usual gait speed (in seconds)
4 secondary outcomes
Screening Time
Time frame: This will be measured at baseline.
Screening Completion
Time frame: This will be measured at baseline.
Change in Number of Hospitalization
Time frame: This will be measured at three months and six months.
Change in Number of Falls
Time frame: This will be measured at three months and six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 31192278Abbasi M, Khera S, Dabravolskaj J, Garrison M, King S. Identification of Frailty in Primary Care: Feasibility and Acceptability of Recommended Case Finding Tools Within a Primary Care Integrated Seniors' Program. Gerontol Geriatr Med. 2019 May 15;5:2333721419848153. doi: 10.1177/2333721419848153. eCollection 2019 Jan-Dec.
- Background: PubMed 31729157Ambagtsheer RC, Thompson MQ, Archibald MM, Casey MG, Schultz TJ. Diagnostic test accuracy of self-reported screening instruments in identifying frailty in community-dwelling older people: A systematic review. Geriatr Gerontol Int. 2020 Jan;20(1):14-24. doi: 10.1111/ggi.13810. Epub 2019 Nov 14.
- Background: PubMed 23170783Fukutomi E, Okumiya K, Wada T, Sakamoto R, Ishimoto Y, Kimura Y, Kasahara Y, Chen WL, Imai H, Fujisawa M, Otuka K, Matsubayashi K. Importance of cognitive assessment as part of the "Kihon Checklist" developed by the Japanese Ministry of Health, Labor and Welfare for prediction of frailty at a 2-year follow up. Geriatr Gerontol Int. 2013 Jul;13(3):654-62. doi: 10.1111/j.1447-0594.2012.00959.x. Epub 2012 Nov 22.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 19682112Kiely DK, Cupples LA, Lipsitz LA. Validation and comparison of two frailty indexes: The MOBILIZE Boston Study. J Am Geriatr Soc. 2009 Sep;57(9):1532-9. doi: 10.1111/j.1532-5415.2009.02394.x. Epub 2009 Jul 21.
- Background: PubMed 26927924Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Ru Lin, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Ru Lin, PhD (886-2-28227101 ext. 2300, hungru@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frailty Phenotype (FP) (time frame: This will be measured at baseline, three months and six months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835090, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.